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Completed

NCT Number: NCT00921739

Esophageal Sparing Intensity-modulated Radiation Therapy (IMRT) for Locally-Advanced Thoracic Malignancies

Hypothesis 1- Using IMRT, the radiation therapy (RT) dose can be safely escalated from 58 Gy to 74 Gy given as 6 fractions/week with concurrent chemotherapy.

Hypothesis 2- Esophageal motion can be used to customize planning organ at risk volumes.

Hypothesis 3- Biological predictors of acute esophagitis can be used to identify patients at high risk of developing esophageal toxicity from radiation therapy and chemotherapy.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Hemic and Lymphatic Diseases Lung Diseases Lung Neoplasms Lymphatic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Cancer Small Cell Lung Carcinoma Thoracic Neoplasms Thymoma Thymus Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

Prospective phase I study designed to determine the maximum tolerated dose of radiation therapy given in an accelerated fashion (2 Gy/fraction, 6 fractions/week) with concurrent chemotherapy. Intensity-modulated radiation therapy (IMRT) will be utilized to spare the esophagus. All patients on the dose escalation study will participate in additional assessments evaluating esophageal motion and esophageal toxicity from radiation therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologic documentation of one of the following thoracic malignancies:
  • Non-small cell lung cancer (stage III or X (recurrent) with disease confined to local/regional sites)
  • Small cell lung cancer (stage II-III)
  • Thymoma (unresectable)
  • Thymic carcinoma (unresectable)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Weight loss < 10% in preceding 3 months prior to diagnosis
  • ANC > or = 1500 and platelet count > or = 100,000.
  • Creatinine clearance greater than 50 ml/min
  • 18 years of age or older.
  • Negative pregnancy test in women of child-bearing potential

Exclusion criteria

  • Prior thoracic irradiation
  • Medical contraindications to thoracic irradiation

Treatment and study plan

Esophageal sparing IMRT

Radiation

6 fractions/week of 2Gy each for 29 fx (58 Gy), 31 fx (62 Gy), 33 fx (66 Gy), 35 fx (70 Gy), or 37 fx (74 Gy).

Primary outcomes

  1. Maximum tolerated dose (MTD) of IMRT

    Time frame: within 30 days of completing RT

Secondary outcomes

  1. The occurrence of RT-induced acute esophagitis

    Time frame: One year

  2. To determine if biological predictors of esophagitis can identify patients who develop severe esophageal toxicity during radiation therapy

    Time frame: Two years

    Blood will be drawn at specific time intervals, plasma will be analysed for Glutathione Oxidation, Citrulline, Lipid peroxidation, DNA oxidation, and Tetrahydrobiopterin.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Phase I Dose Escalation Study of Accelerated Fractionation With Esophageal Sparing Using Intensity-Modulated Radiation Therapy for Locally-Advanced Thoracic Malignancies Including a Prospective Assessment of Esophageal Motion and Radiation-Induced Esophageal Injury

Acronym: ESIMRT

Important dates

Study start
2009
Primary completion
2014
Study completion
2016
First posted
Jun 16, 2009
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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